ACIP Recommends Routine PCV13 Immunization for Adults 65 and Older

Group Holds Special Meeting to Discuss, Vote on Pneumococcal Vaccines

The CDC's Advisory Committee on Immunization Practices (ACIP) held a special meeting(www.cdc.gov) Aug. 13 to discuss and vote on the use of pneumococcal vaccines in older adults. The meeting concluded with the committee recommending routine immunization with 13-valent pneumococcal conjugate vaccine (PCV13) for adults 65 or older.

The special session was convened prior to the regularly scheduled meeting in October to ensure any such recommendation was made as quickly as possible, said AAFP liaison to the ACIP Jamie Loehr, M.D., of Ithaca, N.Y. Doing so will allow physicians to discuss PCV13 vaccination with patients who are already visiting the office to receive the annual influenza vaccine, he said.

Recommendation Specifics

The recommendation addressed specifics of who and when to vaccinate, as well as about initiating a discussion with patients regarding additional vaccination steps.

First, the recommendation calls for offering a dose of the PCV13 vaccination, marketed by Pfizer Inc. as Prevnar 13, to adults age 65 or older who have not previously received a pneumococcal vaccine or whose previous vaccination history is unknown. The recommendation then notes that physicians should recommend a dose of the 23-valent pneumococcal polysaccharide vaccine (PPSV23), marketed by Merck and Co. as Pneumovax, for these patients six to 12 months after PCV13 vaccination.

Story highlights

The CDC's Advisory Committee on Immunization Practices (ACIP) held a special meeting Aug. 13 that culminated in a vote to recommend routine immunization with 13-valent pneumococcal conjugate vaccine (PCV13) for adults 65 or older.

The ACIP also recommended that a dose of 23-valent pneumococcal polysaccharide vaccine be administered to these patients six to 12 months after PCV13 vaccination.

Currently, Medicare only pays for one dose of pneumococcal vaccine for patients older than 65.

Secondly, the recommendation states that if a patient 65 or older has not previously received the PCV13 vaccine but has received one or more doses of PPSV23, that patient should receive a dose of PCV13 at least one year after administration of the most recent dose of PPSV23.

If an additional dose of PPSV23 is indicated, that dose should be given six to 12 months after PCV13 vaccination and at least five years after the most recent dose of PPSV23.

The ACIP recommendation becomes valid only after it is approved by the CDC director and subsequently published in the CDC's Morbidity and Mortality Weekly Report, Loehr explained.

Supporting Evidence

The decision to recommend PCV13 vaccination was supported by evidence from the Pfizer-sponsored Community-acquired Pneumonia Immunization Trial in Adults (CAPiTA) study(www.pfizer.com) that was conducted in the Netherlands.

The CAPiTA study involved almost 85,000 participants 65 or older, half of whom received the PCV13 vaccine and the other half of whom received a placebo. In the vaccine group, about 45 percent fewer first episodes of vaccine-type community-acquired pneumonia were seen compared to the placebo group. Also, a 75 percent reduction in vaccine-type invasive pneumococcal disease was seen in the vaccine group compared with controls.

"So it was pretty clear (from the evidence) that for vaccine-naïve people who had not received Pneumovax, getting this vaccine significantly decreased their risk of serious illness," Loehr said.

Limitations of the study included that it was industry-sponsored and no participants had previously received the PPSV23 vaccine, he said.

"So there is no evidence, explanation or understanding of what happens to people who have had PPSV23 (regarding) how much PCV13 helps in addition," Loehr said.

Medicare Coverage

Ideally, physicians would give both the PCV13 and PPSV23 vaccines separated by six months to a year to retain the initial vaccine's efficacy. But currently, Medicare only pays for one dose of pneumococcal vaccine for patients older than 65.

According to Loehr, Jan. 1, 2016, is the earliest the Medicare representative at the ACIP meeting thought Medicare might be able to take the ACIP recommendation into account and approve coverage for two pneumococcal vaccines for those 65 or older.

"So someone walks in who just turned 65 last month -- it's very easy -- you give them PCV13," Loehr said, "or if someone has never had a pneumococcal vaccine, they could be 72, and the decision is straightforward to give them the PCV13 vaccine."

However, if a patient is 67 and had the PPSV23 vaccine two years ago, the new ACIP recommendation calls for administration of the PCV13 vaccine, but Medicare won't currently pay for it. The PCV13 vaccine costs between $135 and $150 and the patient would have to pay for it out-of-pocket. The upshot: There will be patients who turn down the second vaccine because it is expensive, said Loehr.

If a patient who is 65 or older hasn't enrolled in Medicare and still carries insurance from a traditional insurance provider, a second pneumococcal vaccine should be more easily covered, Loehr said, because these insurers are required to follow ACIP guidance and they have to do so more quickly than Medicare.

Reassessing the Recommendation

During the recent meeting, ACIP members also addressed re-evaluating the PCV13 vaccination recommendation in 2018. At that point, they decided, the recommendation could be revised if needed.

In addition to monitoring the impact of the new recommendation in adults age 65 or older who receive the vaccine, the group also suggested monitoring disease trends among PCV13-naïve adults to evaluate the effects of herd immunity and the long-term utility of routine PCV13 use.

The history of the seven-valent pneumococcal conjugate vaccine that was released in 2000 and was for years recommended for infants and children could foreshadow what's to come for PCV13, which is the version now recommended for these young patients.

"By (December 2010), those seven strains not only were very rare in children, but they also were very rare in adults, as well," Loehr said. "So the presumption is, by the end of eight to 10 years after PCV13 has become widely adopted, there won't be that many of those particular strains of pneumococcal disease still hanging around.

"If that is true, then the cost/benefit analysis of this vaccine changes dramatically. By vaccinating a number of children, you have actually protected most of the adults."